Yesterday, Boston Scientific,MicroPortBeckman Coulter,Anqi Medical and Ethicon, among five enterprises, initiated a voluntary recall of their products.

Boston Scientific Corporation Initiates Voluntary Recall of Single-Use Sphincterotome

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. reported that due to the presence of foreign objects in the enclosed part of the cutting wire between the handle and the distal end of the product, Boston Scientific Corporation initiated a voluntary recall of its single-use Cannulating Sphincterotome (Registration No.: 20173010673). The recall is classified as a Level 2 Recall. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the "Medical Device Recall Report."

Attachment: Medical Device Recall Incident Report Form

June 27, 2024

MicroPort Orthopedics, Inc. Voluntarily Recalls Total Hip System

MicroPort Scientific Corporation reported that due to incorrect product label information and other reasons, MicroPort Orthopedics, Inc. voluntarily recalled its Hip System (Registration No.: 20153131657) for total hip replacement. The recall level is Class III. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the Medical Device Recall Report.

Attachment: Medical Device Recall Event Report Form

June 27, 2024

Beckman Coulter, Inc. (USA) Initiates Voluntary Recall of Fully Automated Chemiluminescence Immunoassay Analyzer

Beckman Coulter Commercial Enterprise (China) Co., Ltd. reported that due to the possibility of product oxidation over time, which could cause communication interruptions between subsystems within the analyzer, Beckman Coulter, Inc. (USA) has voluntarily recalled its fully automated chemiluminescence immunoassay analyzer, DxI 9000 Access Immunoassay Analyzer (Imported Medical Device Registration No. 20242220249). The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the "Medical Device Recall Event Report."

Attachment: Medical Device Recall Event Report Form

June 27, 2024

AngioDynamics, Inc. Initiates Voluntary Recall of Perfusion Systems

Shanghai Meichuang Medical Device Co., Ltd. reported that due to a manufacturing defect in the O-ring of the rotating adapter, which may cause drug leakage during infusion, the manufacturer AngioDynamics, Inc. voluntarily recalled its Infusion System (Registration No.: Guo Med Reg In 20183031982). The recall is classified as a Level 2 recall. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the "Medical Device Recall Event Report."

Attachment: Medical Device Recall Incident Report Form

June 27, 2024

Ethicon LLC Initiates Voluntary Recall of Absorbable Hemostatic Gauze

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported that due to reasons such as damage to the sterile barrier of the primary packaging of some products, Ethicon LLC, the manufacturer, voluntarily recalled its absorbable hemostatic gauze SURGICEL Absorbable Hemostat (Registration No.: 20153141908). The recall level is Class II. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the "Medical Device Recall Event Report Form."

Attachment: Medical Device Recall Event Report Form

June 27, 2024